Capitainer®B 50
![[.NL-en Netherlands (english)]](/fileadmin/_processed_/9/b/csm_CAPITAINER_B50_CARD___HAND_01_WEBB_NEW__1__8babd5ef63.png "[.NL-en Netherlands (english)]")
![[.NL-en Netherlands (english)]](/fileadmin/media/f100/Products/CAPITAINER_B50_CARD___HAND_01_WEBB_NEW__1_.png "[.NL-en Netherlands (english)]")
For a larger blood sample volume
- Allows applications of multiple drops until metering channel is filled
- Automatically meters 2×50µl of blood
- Designed to minimize the risk of over- or under-fill
- Successful sampling indicator integrated in the device
- Sample protected from contamination within the device
Capitainer®B 50 accurately collects 50 μl whole blood from finger stick. It is developed to be easy to use with guarantied sample quality. Capitainer’s paper based drying pouch allows the sample to dry during transportation. No drying step is required by the user. All aspects of the device are designed to make sampling easy for the user.
| Size | |
| Product dimensions | 78 x 43 x 4 mm |
| Sample disc diameter | 6 mm |
| Sample volume | 2 x 50 +/- 0,98 µl |
| Material | |
| DBS paper: | Ahlstrom grade 320 |
| Accuracy | |
| Standard deviation | less than 0.98 μl (CV < 2%). |
| Probability of overfilling or underfilling | (deviation> 3 SD) < 1%** |
| Risk of no sample | < 1%** |
| Operating conditions | |
| Temperature range | +15°C to +35°C |
| Relative humidity range | 15% to 90% |
| Hematocrit value | 25% to 55% |
The card must be used within 30 minutes from opening the package
Sample Storage
Collected qDBS samples can be stored at room temperature.
The stability of individual analytes in DBS samples should be validated by the responsible laboratory. In general, stability increases with lower temperature and lower humidity. qDBS discs can be stored in the freezer to extend stability. Please refer to the extensive literature for traditional DBS samples as guidance for individual analytes.
Disposal
Dispose according to local regulations. Take care with blood stained materials and sharps.
Regulatory
Capitainer®B 50 is CE-marked, registered as an IVD product according to the IVD Regulation (EU) 2017/746 and registered with the US FDA as a Device Class 1.
**Success run testing with safety delay: ∆T>6seconds, 35 and 45% Hematocrit,Reliability 99%, Confidence 95%, n=300, 0 failures accepted.
Responsible Manufacturer: CAPITAINER AB | Solna Torg 19 | SE-171 45 Solna | SWEDEN
Sysmex Nederland B.V.
Ecustraat 11
4879 NP Etten-Leur
The Netherlands
+31 (0)76 508 6000
+31 (0)76 508 6086
Sysmex Belgium N.V.
Chaussée de Bruxelles 135A
1310 La Hulpe
Belgium
+32 (0)2 769 7474
+32 (0)2 7697499
